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GEPW - Manufacturing Engineer II

Boulder, CO

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Description: Manufacturing Quality Engineeru00a0 Job Title: Manufacturing Quality Engineeru00a0 Description:u00a0 The Manufacturing Quality Engineer will provide quality planning, control, improvement, and reliability testing to support product development teams, manufacturing engineering, supply management, and manufacturing and/or distribution organizations to assure product quality meets customers' expectations. This role includes responsibility for Quality Control testing, support of customer studies, testing of returned products, root cause failure analysis, corrective action and partnering with Manufacturing Engineering to drive continuous improvement. This position will also be working with teams and suppliers to ensure standard and consistent manufacturing quality requirements and standards are met.u00a0 Essential Functions/Responsibilitiesu00a0 u2022 Development of quality processesu00a0 u2022 Build sustainable manufacturing quality processesu00a0 u2022 Drive pro-active quality using value stream mapping and process failure mode effects analysis (PFMEA)u00a0 u2022 Support process monitoring and control in manufacturingu00a0 u2022 Execute validations, reliability test plans, and product stability studiesu00a0 u2022 Support customer studiesu00a0 u2022 Conduct Design of Experiments for critical product parametersu00a0 u2022 Perform root cause failure analysis and lead the execution of root cause corrective actions.u00a0 u2022 Participate on quality improvement teamsu00a0 u2022 Engage in applying/leading quality toolsu00a0 u2022 Encourage early interaction of both customer and supplier input to team activitiesu00a0 u2022 Monitor and facilitate quality activities for parts approvalu00a0 u2022 Engage in applying/leading quality tools for customer support process, continuous improvement, and/or value improvement teamsu00a0 u2022 Execute quality control plan where implementedu00a0 u2022 Investigate product quality problems, determine root cause, and implement corrective actionu00a0 u2022 Assist in identifying supplier quality problemsu00a0 u2022 Conduct internal audits of company processes for conformance to ISO 9001:2015 and adherence to accepted quality practicesu00a0 u2022 Identify and drive preventive actionsu00a0 u2022 Facilitate and write quality procedures for maintaining/updating the manufacturing quality system, supports quality system audits, and reviews results with audit team.u00a0 Provide training and/or supervision to co-workers, inspectors, technicians and auditors on quality procedures and tools to monitor critical processes to assure consistent control and/or to implement cost-saving ideas to improve our products to meet customer expectationsu00a0 Qualifications/Requirementsu00a0 Bachelor's Degree in Chemistry, Chemical Engineering, Bio-Chemical Engineering, Mechanical Engineering or related degree/programu00a0 Skills and Abilitiesu00a0 u2022 Manufacturing knowledge/experienceu00a0 u2022 Process improvement methodology and experienceu00a0 u2022 Testing knowledge/experience of analytical instrumentsu00a0 u2022 Quality Monitoring and Control knowledgeu00a0 u2022 Sampling theoryu00a0 u2022 Collecting and summarizing large amounts of datau00a0 u2022 Continuous improvement experienceu00a0 u2022 Statistical Process Control (SPC)u00a0 u2022 Failure analysis and troubleshooting of complex productsu00a0 u2022 Root cause analysis and corrective actionu00a0 u2022 Excellent oral and written communication skills to communicate complex datau00a0 u2022 Experience in International Quality Standards, particularly ISO 9001:20015u00a0 u2022 Awareness of cGMP standards

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